DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2020-0102905, filed on 08/17/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamori et al. (JP 2009083185 A, hereinafter Kawamori) in view of Asai et al. (CN 103269955 B, hereinafter Asai).
Regarding claim 1, Kawamori discloses a method of marking a letter or number (Abstract, “To clearly and efficiently put marking such as a lot number, a best before date, etc., on the surface of a package.”) on a surface of a rubber substrate (Abstract, “resin that changes color by heat of the laser beam absorbent, and solvent that dissolves resin is printed. For the resin, cellulose nitrate, acrylic resin, urethane resin, polyamide resin, chlorinated polypropylene resin, chlorinated rubber, polyester, or mix of these can be used.”, where chlorinated rubber can be used as a substrate that receives markings) by irradiating the surface of the rubber substrate (Page 4, Para. 2 from end, “marking could be applied to the surface of the packaging material in which the polyethylene layer”, where the polyethylene layer could also be chlorinated rubber as an alternative material)
at a power of 10 to 16 W (Page 3, last Para., “The laser device that can be used in the present invention has an average output of 6 W or more, preferably 13 W or more”)
with a short pulse laser having a pulse width of 2 to 6 ns (Page 3, last Para., “a pulse width of 6 ns or less, preferably 4 ns or less.”) and
a peak power of 75 to 125 kW (Page 3, last Para., “a peak power of 30 kW or more”, where 75-125 kW falls under being greater than 30 kW).
Kawamori does not disclose:
where the substrate is a rubber stopper.
However, Asai discloses, in the similar field of chlorinated rubber substrates (Page 4, Para. 2, “the top surface of the cover 3 and the piercing region 2 are made of chlorinated butyl rubber”), where the substrate can be a rubber stopper for a drug bottle (Page 4, Para. 2, “rubber plug 1 of the cover 3 of the top face of the rubber is not particularly limited, and if the rubber with the rubber hardness of core caused by penetration of hollow needle, for piercing region 2 of rubber is not particularly limited. In the above embodiment, the top surface of the cover 3 and the piercing region 2 are made of chlorinated butyl rubber”; and Page 2, Para. 1, “a vial or ampoule as little drug solution of storage container. small container bottle, mainly made of glass, plastic or the like is sealed, the opening part of container is covered by rubber plug.”). It would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the chlorinated rubber substrate in Kawamori to be a stopper as taught by Asai.
One of ordinary skill in the art would have been motivated to make this modification in order to gain the advantage of using the markable substrate in a drug field, where the chlorinated rubber has a smaller permeability that does not degrade in the presence of drugs, as stated by Asai, Page 4, Para. 2, “chlorinated butyl rubber for rubber with high rubber hardness and a low rubber hardness of rubber. the chlorinated butyl rubber has a smaller permeability and not be drug degradation and drug elution, preferably using the rubber.”.
Regarding claim 2, modified Kawamori teaches the method according to claim 1, as set forth above, discloses wherein the letter or number is marked on a front or rear surface of the rubber stopper (Kawamori, Page 4, Para. 2 from end, “marking could be applied to the surface of the packaging material in which the polyethylene layer”, where the polyethylene layer could also be chlorinated rubber as an alternative material; teaching from Asai, Page 4, Para. 2, “rubber plug 1 of the cover 3; where the entire rubber plug of Asai is made from chlorinated rubber, where the surface marking of the chlorinated rubber by a laser from Kawamori could then be applied to any surface of the rubber plug from Asai, where those surfaces include the front or rear surfaces).
Regarding claim 3, modified Kawamori teaches the method according to claim 1, as set forth above, discloses wherein the rubber stopper is a drug bottle cap or a syringe nozzle cover (Teaching from Asai, Page 2, Para. 1, “a vial or ampoule as little drug solution of storage container. small container bottle, mainly made of glass, plastic or the like is sealed, the opening part of container is covered by rubber plug.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN GUANHUA WEN whose telephone number is (571)272-9940 and whose email is kevin.wen@uspto.gov. The examiner can normally be reached Monday-Friday 9:00 am - 5:00 pm.
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/KEVIN GUANHUA WEN/Examiner, Art Unit 3761
12/01/2025